Regulatory Labelling Associate

Plantacnd360

Base: not specified; bonus/equity: cash-based ince...
Gmp and fda compliance
Label creation and control
Fda udi gudid database management
By living according to a common set of values, we create a culture that unifies, embraces the uniqueness we all bring to the company, and positions Integer for long-term success

Job Summary

  • By living according to a common set of values, we create a culture that unifies, embraces the uniqueness we all bring to the company, and positions Integer for long-term success.
  • The role involves preparing, creating, and controlling labels and instructions for use according to procedures, ensuring compliance with regulatory and quality standards.
  • Our total rewards program is designed to attract, retain, and motivate associates to contribute to Integer’s success, including comprehensive benefits and a pay-for-performance philosophy.

Matching Summary

By living according to a common set of values, we create a culture that unifies, embraces the uniqueness we all bring to the company, and positions Integer for long-term success.

Salary

Base: Not specified; Bonus/Equity: Cash-based incentive program; Benefits: Medical, dental, vision, disability, life insurance, adoption benefits, 401(k) with company match, paid time off

Skills & Requirements

Must-have

  • GMP and FDA compliance
  • Label creation and control
  • FDA UDI GUDID database management
  • Adobe InDesign proficiency
  • Change Control process experience
  • Labeling translation management

Nice-to-have

  • Strong organizational skills
  • Collaboration with cross-functional teams
  • Continuous improvement mindset
  • Strong attention to detail
  • Technical support for label printing

Key Requirements

  • Minimum 3 years GMP and FDA experience
  • General understanding of U.S. FDA UDI and EU MDR labeling
  • Experience with Change Control process

Work Rights

Not specified

Tailored Resume

Cover Letter